March 5-6, 2012 | Baltimore, MD

ABOUT THE CONFERENCE

Throughout the US, medical device corporations face daily challenges in conducting their clinical research studies that are entirely different and more challenging than the hurdles faced by the pharmaceutical industry. This vibrant and quickly evolving industry has for many years looked to Q1 productions as their source of education and networking opportunities as they look to structure and conduct clinical studies that meet various internal and external expectations. In our 6th Annual US Medical Device Clinical Research conference, we will focus on a wide range of the specific challenges that the device industry faces, throughout their clinical trial. Also of great importance and relevance will be evolutions in the regulatory framework, along with the recent 510k changes that have so dramatically impacted the industry.

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TOPICS TO BE COVERED

• Recent Changes In FDA Approval Pathways for Medical Devices
• In-Depth Analysis of New Pre-Market Approval Regulations & Their Effect on the Device Industry
  
• Strategic Methods of Approaching FDA Pre-IDE to Optimize Outcome
  
• Aligning Clinical Trial Design to Meet Clinical Trial End-Goals
  
• Successfully Selecting and Managing Clinical Trial Sites
  
• Outlining the Significance of Medical Affairs in Device Research
  
• Recruitment Strategies: Attracting the Most Suitable Participants
  
• Improving Patient Safety & Protection in Device Clinical Studies
  
• Comparative Effectiveness Research & the Future for Device Clinical Research
  
• Successfully Managing Outsourced Clinical Trials
  
• Conducting Clinical Trials in Europe: Weighing the Pros and Cons
  
• Panel Discussion: Overcoming Possible Funding Obstacles
  
• Conducting Post Market Surveillance to Meet Regulatory Expectations
  
• Defining Additional Opportunities to Utilize Clinical Research Data
  
• Analyzing Unforeseen Challenges and Solutions in Clinical Research
  
• Utilizing Failure Modes and Effect Analysis to Improve Overall Trial

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ADD TO CALENDAR

KEY PRESENTERS TO INCLUDE

Mary Beth Ritchey, RN, MSPH, PhD
Associate Director for Postmarket Surveillance Studies Division of Epidemiology, Office of Surveillance & Biometrics
CDRH, FDA

Lynne Kelley MD, FACS
World Wide Vice President, Medical Affairs, Medical Surgical Systems
Becton, Dickinson & Company

Gabor Oroszlan, MD
Global Clinical Research Director
Medtronic

David L Horwitz, MD PhD FACP
Chief Medical Officer
Johnson & Johnson Diabetes Institute

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